13 years of warnings, FDA inaction behind seizure

U.S. marshals seized a number of drug products from a small New Jersey pharmaceutical manufacturer called Tri-Med laboratories earlier this month. It doesn’t sound like much, and there hasn’t really been any coverage beyond a press release, but Pharmalot’s Ed Silverman has the whole story, one that chronicles 13 years of failed inspections and FDA inaction.

You’d do best to just read Silverman’s post, “Thirteen Years Later, The Feds Seize Some Meds,” but here’s a summary:

In 1997, the FDA inspected and warned TriMed. Seven years later, they did it again. In 2009, it was time for yet another encore. Finally, this month, they took action and seized a few drugs, stating in the release that, as Silverman writes, “Tri-Med has been making and distributing unapproved, misbranded and adulterated drugs with significant manufacturing violations since 1997.” And it only took them several failed inspections (and a recall along the way) to realize it.

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